Hub Submission Manager (Regulatory)

SRG; Stone Cross; On-site; GBP 60,000 - 85,000; Full time

Job summary

SRG is seeking an experienced Hub Submission Manager to join a global regulatory operations team within a highly regulated pharmaceutical environment. The role focuses on managing regional and national submissions from planning to archival to ensure compliant, timely delivery.

You will coordinate activities across markets, drive improvements in submission processes, and provide expertise to colleagues and project teams in a fast-paced setting.

Qualifications

• Experience coordinating regulatory submissions in pharma, biotech, or life sciences.
• Strong project management and organisational skills across multiple priorities.
• Knowledge of regional and national filing guidelines and dossier structures.
• Experience with electronic submission systems and regulatory technologies.
• Bachelor's degree in Pharmacy or Life Sciences, or equivalent experience.
• Excellent communication and stakeholder management across global teams.

Responsibilities

• Lead and coordinate regulatory submission activities for products and markets.
• Plan, compile, build, and deliver electronic and paper dossiers to authorities.
• Collaborate with regulatory teams, country reps and external stakeholders on requirements and timelines.
• Monitor milestones and resolve issues impacting delivery schedules.
• Drive process improvement and regulatory technology advancements.
• Act as subject matter expert, providing guidance and training.

Skills

Regulatory submissions

Project management

Stakeholder management

Electronic submission systems

Regulatory technologies

Education

Bachelor's degree in Pharmacy

Life Sciences or related discipline

Tools

Electronic submission systems

Document management platforms

Job description

We are seeking an experienced Hub Submission Manager to join a global regulatory operations team within a highly regulated pharmaceutical environment. This position is responsible for the operational management, coordination and delivery of regional and national regulatory submissions to health authorities, ensuring compliance with regulatory requirements and critical business timelines. The successful candidate will work across multiple markets and stakeholders, managing submission activities from planning and dossier preparation through to delivery and archival, while driving process improvements and operational excellence.

Key Responsibilities

• Lead and coordinate regulatory submission activities for assigned products, markets and regulatory procedures.
• Manage the planning, compilation, technical build and delivery of electronic and paper regulatory dossiers to health authorities worldwide.
• Partner with regulatory teams, country representatives and external stakeholders to ensure submission requirements, timelines and translation activities are effectively managed.
• Monitor submission milestones, identify risks and proactively resolve issues that could impact regulatory delivery schedules.
• Drive continuous improvement initiatives, supporting the development and implementation of more efficient submission processes and technologies.
• Act as a subject matter expert for submission processes, providing guidance, training and support to colleagues and project teams.

Skills, Experience & Qualifications

• Experience coordinating regulatory submissions within a pharmaceutical, biotechnology or life sciences environment.
• Strong project management and organisational skills, with the ability to manage multiple complex priorities simultaneously.
• Knowledge of regulatory submission requirements, dossier structures and applicable filing guidelines across regional and national markets.
• Experience with electronic submission systems, document management platforms and regulatory technologies.
• Bachelor's degree in Pharmacy, Life Sciences, Business, Information Technology or a related discipline, or equivalent professional experience.
• Excellent communication and stakeholder management skills, with the ability to work effectively across global teams and multicultural environments.

What's on Offer

• Opportunity to work within a global regulatory operations function supporting international product submissions.
• Exposure to a wide range of markets, regulatory procedures and health authority interactions.
• Collaborative environment with opportunities to contribute to process improvement and innovation.
• Involvement in business-critical projects supporting the development and maintenance of pharmaceutical products.

If you thrive in a fast-paced regulatory environment and have a passion for delivering high-quality submissions on a global scale, we would love to hear from you.